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Wednesday, October 15, 2014

OraSure Technologies is examining whether technology it developed for its in-home HIV test could be used to screen for Ebola.

The company has been approached by federal agencies and private-sector entities interested in employing the method, which detects antibodies in saliva, to test for Ebola, said President and CEO Douglas A. Michels. He would not specify which government agencies or companies are involved.

"We have been approached by different organizations that have expressed an interest in possibly exploring that with us, and at this point in time we're determining the path forward, as it relates to work that might be involved in developing such a capability," Michels said.

OraSure's testing technology is attractive because it is easy to use, produces a quick result and unlike current Ebola tests, does not require blood to be drawn.

Food and Drug Administration Commissioner Dr. Margaret A. Hamburg said "point-of-care diagnostics" like those produced by OraSure are critical to providing the right treatment and public health response to contain an epidemic.

"The ability to do a rapid diagnostic is key," she said. "I think you are right on the money in terms of the value of that kind of technology being applied in a public health crisis like Ebola."

She and Michels would not speculate where such a test, if developed, could be used, whether to screen patients at hospitals or travelers at airports for the virus.

The Ebola virus has sickened an estimated 8,900 in West Africa, killing more than 4,400. The World Health Organization predicted Tuesday that the rate of infection in Liberia, Guinea and Sierra Leone could hit 10,000 a week by the end of the year.

One person has contracted Ebola in the U.S., a nurse who treated Liberian national Thomas Eric Duncan at a Dallas hospital. Duncan died of the disease last week after returning from Liberia. The 26-year-old nurse, Nina Pham, remains hospitalized.

OraSure's OraQuick rapid in-home HIV test uses a cheek swab to collect saliva. It produces a result in as little as 20 minutes. It works like a conventional pregnancy test, showing a reading on a hand-held indicator.

That's a big plus, Hamburg said, especially in West Africa where many patients are skeptical of or reluctant to engage the public health system. A cheek swab is a lot less intimidating than having your blood taken, Hamburg said. It's also safer than taking blood because it eliminates the risk of needle sticks.

"Clearly the OraSure approach and demonstrated track record makes that kind of technology quite attractive as a possibility, but there are other approaches that also are being studied," she said.

Michels said research has shown that the Ebola virus and antibodies to the virus are detectable in saliva.

"There is an extraordinary level of interest, there is urgency, there has been a high level of activity in recent weeks," Michels said. "It is yet to be proven whether we can develop a product on the platform. We believe we could, but obviously a lot of work has to go into that before we have the empirical data."

Testing and development of an Ebola test will not involve bringing the virus to the company's South Side Bethlehem headquarters. It is restricted to highly controlled Biosafety Level 4 facilities operated by the government and certain research facilities.

"There would certainly have to be validation activities that would require a BL4 facility," Michels said. "That is where relationships with different government entities and research entities have become so critically important."

Besides looking for new diagnostic tools, the FDA is working to accelerate development of vaccines and treatments for Ebola and has transferred resources and staff to those tasks, Hamburg said.

Part of that involves helping to design clinical trials to determine their efficacy and safety.

"My hope is that we will be able to get some meaningful answers in the time frame of this outbreak, which sadly is not going to resolve in the immediate near term," she said. "I think we certainly want to be better equipped for the next outbreak as well."

Since 2002, the FDA and OraSure have worked closely on approval of several first-of-their-kind medical-testing products, including the rapid oral fluid HIV test and in-home HIV test, as well as a rapid test for hepatitis C.